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NCT02311972 · ClinicalTrials.gov registry record · NA
Temperature Monitoring With InnerSense Esophageal Temperature Sensor/Feeding Tube After Birth Through Stabilization in VLBW Infants
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 52
- Enrollment target
NCT02311972 is a NA study that has completed, run by Duke University. The registered enrollment target is 52 participants.
The verdict
NCT02311972, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 52 participants
- Enrollment target
Study Summary
Very low birth weight (VLBW) infants (\<1500 grams at birth) and other low birth weight infants experience hypothermia after birth and through stabilization (first 24 hours of life) due to an inability to keep warm through metabolic heat production while experiencing heat loss during care. The investigator hypothesizes that inserting an InnerSense oral gastric tube (Philips Healthcare) with its imbedded thermistor and attaching the tube to a temperature monitor with a digital temperature display will enable care-providers to monitor continuous body temperature and prompt them to provide warmth and prevent heat loss, thus preventing hypothermia in these infants for the first 24 hours of life. The investigator predicts infants in the intervention group will have warmer axillary temperatures upon admission to the NICU and at 1, 4, and 8 hours of age. Mothers in non-active labor will be sought for consent to enroll their VLBW infant into this study after the infant's birth. 160 VLBW infants and other low birth weight infants 1000-2000 grams will be randomized to the intervention group (placement of InnerSense oral gastric tube with thermistor to a Squirrel monitor for continuous digital temperature display, immediately after birth through 24 hours of life) or the control group (standard delivery room care and stabilization care). The study staff plans to enroll 180 infants (90 per group) to allow for screen failures. Axillary temperatures of all infants will be recorded at NICU admission, 1, 4, 8 and 24 hours of age. Further, the study staff intends to enroll approximately 300 Intensive Care Nursery providers who care for an InnerSense study infant and wish to complete a provider satisfaction survey. These providers will be asked to provide consent prior to completing the survey and their names will be recorded on a separate study enrollment log. Infant demographic data will be compared to make sure groups are not significantly different. Temperatures from the interve
Interventions
- DEVICE Philips InnerSense Esophageal Temperature Sensor/Feeding Tube
- DEVICE Standard of care feeding tube
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2014-11 |
| Est. Completion | 2016-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02311972
The ClinicalTrials.gov registry entry for NCT02311972 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Philips InnerSense Esophageal Temperature Sensor/Feeding Tube is the first listed.
NCT02311972 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02311972 about?
NCT02311972 is a clinical study titled "Temperature Monitoring With InnerSense Esophageal Temperature Sensor/Feeding Tube After Birth Through Stabilization in VLBW Infants". Very low birth weight (VLBW) infants (\<1500 grams at birth) and other low birth weight infants experience hypothermia after birth and through stabilization (first 24 hours of life) due to an inability to keep warm through metabolic heat production while experiencing heat loss during care. The inve...
What is the current status of trial NCT02311972?
This trial is currently completed. It is a NA study. The enrollment target is 52 participants. The study started on 2014-11. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02311972?
The interventions under investigation include: Philips InnerSense Esophageal Temperature Sensor/Feeding Tube (DEVICE), Standard of care feeding tube (DEVICE).
Who is sponsoring clinical trial NCT02311972?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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